2015 articles

96 scientists who signed a letter calling EFSA’s verdict of non-carcinogenicity for glyphosate “flawed” are accused of incompetence and of acting like lobbyists

EXCERPT: Under internationally recognised scientific criteria, five studies in mice showed a significant increase in tumours linked to glyphosate exposure. However, EFSA concluded that “no evidence of carcinogenicity was observed in […] mice”.—

The European Food Safety Authority (ESFA) said on 12 November that there is no scientific evidence that glyphosate – the active ingredient in the world’s most used weedkillers, such as Monsanto’s Roundup – can cause cancer. And so there is no need to classify it in the EU as a “known”, “presumed”, or only “suspected” carcinogen.

This conclusion clashed head-on with the assessment of the world’s most reputable cancer agency: the World Health Organisation’s International Agency for Research on Cancer (IARC). IARC found in March this year that glyphosate was a “probable” carcinogen, based on “limited evidence” of harm in humans and “sufficient evidence” animals.

Under EU law, “sufficient evidence” of carcinogenicity in animals automatically leads to the classification of a pesticide as a “presumed carcinogen” (Class 1B). A “known” or “presumed” carcinogen cannot be sold as a pesticide, according to EU rules.

On 27 November, 96 independent and government scientists – with among them eight of the 17 members of the IARC working group and the chairs of all four subgroups – argued in a letter to EU Health Commissioner Andriukaitis that the EFSA conclusion was “not supported by the evidence”. They said the Commissioner should “disregard the flawed EFSA finding” and “call for a transparent, open and credible review of the scientific literature”.

In a surprisingly personal response, EFSA’s executive director, Bernhard Url, essentially accused the scientists who signed the letter of incompetence and of acting like lobbyists. Here’s what he said during a hearing at the European Parliament on 1 December:

“People that have not contributed to the work, that have not seen the evidence, most likely, that have not had the time to go into the detail, that are not in the process, have signed a letter of support. Sorry to say that, for me, with this, you leave the domain of science, you enter into the domain of lobbying and campaigning, and this is not the way EFSA goes. For me this is the first sign of the Facebook age of science. You have a scientific assessment, you put it in Facebook and you count how many people like it. For us, this is no way forward. We produce a scientific opinion, we stand for it but we cannot take into account whether it will be liked or not.”

Pesticides industry criteria

Also speaking at the Parliament hearing last week, IARC’s Kate Guyton explained that “sufficient evidence” was available from a “significant association for glyphosate” in two separate long-term feeding studies in mice.

EFSA did not only contest these specific IARC findings, but rejected all evidence and animal trials en masse. Again at the hearing, EFSA’s José Tarazona said that IARC applied a statistical method that it shouldn’t have used. According to EFSA, IARC “deviated” from an OECD recommendation that only the “statistical approach used in the study design” must be applied. By this criteria, almost all of the glyphosate-induced tumours observed in experimental mice are off the table.

According to the German Institute for Risk Assessment (BfR), which was responsible for preparing a draft of the EFSA report, a total of five long-term studies in mice (including the two evaluated by IARC) show a statistically significant increase in cancers when IARC’s statistical method (the Cochran Armitage trend test) is applied. The BfR itself didn’t “initial[ly]” use this method because it relied on the statistical evaluation provided by the glyphosate industry, which commissioned the trials.

Remarkably, one of the five studies in mice (examined by BfR but not seen by IARC) showed a significant increase even when the industry’s original statistical approach was used. EFSA dismissed this finding based on various arguments, including by simply saying that the study results were inconsistent with those of the four other mouse studies. EFSA later added that the study was “not acceptable due to viral infections”. [1]

Therefore, under internationally recognised scientific criteria, five studies in mice showed a significant increase in tumours linked to glyphosate exposure. However, EFSA concluded that “no evidence of carcinogenicity was observed in […] mice”.

EFSA’s executive director Url said he was “completely confident” that “the European system, with the member states, with the European Chemicals Agency and with EFSA” had produced “the most comprehensive, the most state-of-the-art assessment of glyphosate that was done up to now”. The Commission’s new director-general for health, Xavier Prats Monne, was equally confident that the glyphosate evaluation “followed the usual, established, regular, stringent process” in the EU.

This is good news for pesticides companies, but bad news for everybody else. If the EU continues to follow this “regular, stringent process” we can expect that about every pesticide will be deemed safe.

This is reminiscent of the tobacco industry’s attempts to establish scientific criteria that are so unrealistic that any proof of harm can be dismissed. Several of these examples are documented in the European Environmental Agency’s Late Lessons from Early Warnings report.

EFSA’s recourse to methods associated with tobacco science is an ominous development, given its central role in EU regulatory decisions.

—————————————-[1] Pesticide Action Network Germany has carried out a detailed analysis of the flaws of the BfR assessment in its Reality Check report.